Study Title

A Phase II, Dose-randomization, Open-label Study to Assess the Safety and Efficacy of PTS in Primary Hepatocellular Carcinoma Patients Who Are Ineligible for Operation or Current Locoregional Therapy

Study ID Numbers

GW-020202

Estimated Enrollment

33 participants (Taiwan), 33 participants (Global)

Outcome  Measures

For BCLC stage B patients with primary Hepatocellular carcinoma (HCC) who are ineligible for operation or current locoregional therapy such as TACE, to evaluate the safety and efficacy of intratumoral injection of PTS.

1. Primary Outcome Measures :

• Objective Response Rate (ORR) [ Time Frame: 4-week post treatment]

2. Secondary Outcome Measures:

• To collect these data: Local Disease Control Rate (LDCR), Time to Treated Tumor Progression (TTTTP), Three-year Overall Survival (OS), and Time to Tumor Stage Progression (TSP) after PTS treatment.
• To evaluate the safety of PTS after intratumoral injection. 
• To evaluate the changes of quality of life scales FACT-Hep and EQ-5D-5L before and after intratumor injection of PTS。

1. Male or female, ≥ 20 years and ≤ 80 years of age.
2. Patients diagnosed with primary, BCLC (Barcelona Clinic Liver Cancer stage) B mid-stage HCC, which are ineffective or unsuitable for resection, liver transplantation, Trans Arterial Chemoembolization (TACE), or current local treatment. If there is any evidence of metastasis or hepatic vascular invasion, patients will be excluded.
3. Female subjects who are pregnant or lactating, any severe disease judged by investigator, or could have allergy and/or hypersensitivity to any of the ingredients of PTS, will be excluded.